Cannabinoids for Behavioral Problems in Children With ASD (CBA)

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This study aims to assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel] for behavioral problems in children and youth with ASD.

Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition. [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]

This is a 24-item parent-rated measure of noncompliant behavior in children with ASD

Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition. [ Time Frame: At 3 months (end of treatment period) ]

This is a 7-point scale designed to measure overall improvement from baseline (CGI-I).

Secondary Outcome Measures :

Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition. [ Time Frame: At 3 months (end of treatment period) ]

This is a 7-point scale designed to measure overall improvement from baseline

Change in Social Responsiveness Scale scores-2 (SRS-2, parent and teacher rated) at three months [ Time Frame: At onset of each treatment period and at 3 months (end of treatment period) ]

This is a 65 item, caregiver (pSRS) or teacher (tSRS) questionnaire, used to determine the severity of social deficit exhibited by participants with ASD. The SRS contains five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Autistic Mannerisms, which respectively measure the ability to recognize social cues, the ability to interpret social cues, the ability to use expressive verbal and nonverbal language skills, the ability to engage in social-interpersonal behaviors, and the tendency to display stereotypical behaviors and restricted interests characteristic of autism

Change in Autism Parenting Stress Index (APSI) score, at three months [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]

This is a 13-item parent rated measure designed to assess the effect of interventions to control disruptive behavior in children with ASD on parenting stress.

Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. [ Time Frame: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period) ]

This is a 24-item parent-rated measure of noncompliant behavior in children with ASD. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition.

Tolerability and adverse effects will be assessed using this modified Liverpool Adverse Events Profile (LAEP) that includes all 19 items of the original LAEP and another 15 items to cover all reported significant side effects of CBD and THC in former studies.

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